NDA Group leads on integrated regulatory and HTA strategy at DIA Euromeeting 2015

Europe’s leading regulatory, pharmacovigilance, and HTA consultancy, NDA Group, will be discussing the benefits of integrating regulatory and HTA strategy at the upcoming 27th Annual DIA EuroMeeting, 13-15th April in Paris, (booth 2.F03, Palais des Congrès).

NDA has been at the forefront of developing services for the life science industry that take advantage of addressing both regulatory and HTA requirements. For close to five years, it has been guiding pharmaceutical companies of all sizes on the direction and actions needed to meet regulators and payer needs in major markets.

“It is now commonly understood that regulatory approval alone is not a guarantee of a drug’s success, and passing the payer hurdle can be even more challenging,” said Johan Strömquist, CEO, NDA Group. “Integrating regulatory and HTA requirements early enough enables drug developers to get the right data in place to increase their chances of gaining access to the European market and reaching end patients faster.”

NDA will have its Health Economics Expert, Professor Bengt Jönsson, available for meetings at the event. Professor Jönsson is chairman of the HTA Advisory Board members. The Advisory Board comprises some of the world’s most prominent and well-respected experts in the fields of regulatory affairs, HTA and pharmacovigilance.  Together, they have supported many global pharmaceutical companies in achieving integrated regulatory/HTA development plans.

NDA talks risk management, ATMPs, EU Clinical Trial reg and disclosure/transparency

In addition to its focus on how to integrate regulatory and HTA requirements in the development process, NDA Group has a strong line-up of speakers at this year’s DIA:

• Shelley Gandhi & Dr Bill Richardson – Moving from risk management to benefit/risk management embedding pharmacovigilance principles into the product life cycle. (Monday 13th April)
• Prof Beatriz Silva Lima – Approval process and experience to date/challenges and successful outcomes of ATMP development. (Tuesday 14th April)
• Dr. Brian Edwards – New EU Clinical Trial Regulation. The alliance for clinical research excellence & safety (ACRES): a mechanism for helping implement the new EU clinical trials. (Tuesday 14th April)
• Dr. Brian Edwards  – Pre-Competitive Collaborations. The ACRES Audit Sharing Project. (Tuesday 14th April)
• Helen Powell – Disclosure & Transparency: considerations on how to audit/ assess compliance for publications & clinical trial disclosure. (Wednesday 15th April)
• Bridget King – Competencies risk management plans (RMPs) – hurdles & opportunities. (Wednesday 15th April)
• Dr Gopalan Narayanan – ATMPs – clinical trial design challenges for ATMPs & medicinal products for rare diseases. (Wednesday 15th April)

Alongside its line-up of speakers, NDA Group will also have present Dr Steffen Thirstrup, Director of the Advisory Board, in addition to its Health Economics Expert, Professor Bengt Jönsson.

To find out more, please visit www.ndareg.com.